Работа в онкологических и ревматологических протоколах II и III фаз клинических исследований. Участие, прохождение аудитов.

Clinical trials management, coordinating and monitoring in accordance with the ICH Guidelines, the current monitor guidelines and SOP’ s including identifying sites, preparing documentation for necessary approvals, initiating sites and observing recruitment, performing monitoring at sites and remote monitoring, reporting visits and contacts with site, assuring the presence of all relevant documents on site, collaborating with other departments for reporting safety information, collecting Case Report Forms, following up and solving data queries, reporting the progress of the study on a regular basis and performing site close-out visits. In 2021 back-up of CLM. Preparation of documents to MoH, conducted quality assessment of protocol translation, preparation of import license, communication with ITM during absence of CLM.

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From 2012 till August 2016 I worked in the Railway clinical hospital at station Novosibirsk-Glavniy. I worked in a Surgical Department of difficult heart rhythm disorders. The most part of patients of this department has an arrhythmia of different etiology. Employees of this department deal with additional patient survey, monitoring ECG, transesophageal electrophysiological research, conservative and surgical treatment, using of anticoagulant drugs, countershock, transesophageal electrostimulation, implantation of pacemaker, pacemaker setting etc.

I worked in Municipal Health Organization “City Clinical Hospital # 34” from 2007 till 2012. I worked in Cardiological Department number 1. There were patients with acute myocardial infarction, unstable angina, chronic heart failure and artrial fibrillations in this department. I worked in the field of additional patient survey, differential diagnosis, treatment. I acted as head of the department. In Municipal Health Organization “City Clinical Hospital # 34” I participated in clinical trial (atrials fibrillations – III phase, acute coronary syndrome – II and III phase, chronic heart failure – III phase). I was responsible for the selection of patients in evaluation of including/excluding criteria, sample collection, ECG, patients treatment in accordance with trial protocol, completion CRF, including safety reporting, using of IVRS. I participated in investigators meetings. I have a certificate GCP-certificate